- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04469309
Comparison of Half-Somersault Exercise With Brandt-Daroff Exercise in BPPV.
Comparison of Half-Somersault Exercise With Brandt-Daroff Exercise in Patients With Posterior Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Khyber Pakhtunkha
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Peshawar, Khyber Pakhtunkha, Pakistan, 25000
- HMC Hospital Peshawar
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed Patients with PC-BPPV
- Age group 25-50 years.
- DHI Scale: 36-42 (moderate handicap)
- Both gender
- Duration of complaints: from the past 6 months
Exclusion Criteria:
- Migraine related dizziness and Anxiety disorder
- Other vestibular conditions are: Acoustic neuroma, Labyrinthitis, Vestibular hypo function, Meniere's disease.
- Any cervical pathology,
- CNS Pathology causing dizziness and vertigo
- Other pathologies which may affect balance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I
Group I will receive Brandoff Exercises
|
In group I Brandoff Exercises will be performed using standard method, in which the patient is in the sitting position on examination table, the patient moves into the lying position on the affected side on the shoulder, with the head angled upward with about 45. The patient stays in this for 30 s and then goes back to the sitting position, looks forward and remains in this position for 30 s as well. The patient repeats the same procedure for the other side, too. The patient performs this maneuver 2 times, twice a day. For total 9 days for 3 weeks. Pre, mid and post assessment. |
Active Comparator: Group II
Group II will receive Somersault exercises
|
In group II Half-Somersault Maneuver will be done, the patient performs this maneuver 2 times, twice a day.
For total 9 days for 3 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vestibular activities and participation measure
Time Frame: Change from Baseline dizziness and balance to 2 Weeks
|
The Vestibular Activities and Participation Measure (VAP) is a 34-item self-report questionnaire that asks the individual to evaluate the effect of dizziness and/or balance problems on their ability to perform activity and participation tasks.The response range from none (0 points) ,moderate (2 points), severe (3 points) unable to do (4 points) to not applicable.
The total score is obtained after calculating the average of the item scale values and excluding the not applicable item scale scores
|
Change from Baseline dizziness and balance to 2 Weeks
|
Dix-Hall pike test
Time Frame: Change from Baseline dizziness to 2 Week
|
Dix-Hall pike is the standard procedure for diagnosis of PC-BPPV.
The Dix-Hallpike Test (DHT) is considered the gold standard assessment for the diagnosis of the vestibular disorder Benign Paroxysmal Positional Vertigo (BPPV).
The Dix-Hallpike test involves rapidly moving the patient from a sitting position to "head hanging," where the patient's head is at least 10 degrees below horizontal.
|
Change from Baseline dizziness to 2 Week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fall efficacy scale (FES)
Time Frame: Change from Baseline dizziness to 2 Week
|
Fall efficacy scale (FES) scale is a measure used to quantify an individual's concern of falling during different tasks.
The FES is a reliable and valid tool for measuring an individual's concern of falling in a sample of people with vestibular disorders.
It consists of 10 activities which are asked from patients.On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, A total score of greater than 70 indicates that the person has a fear of falling.
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Change from Baseline dizziness to 2 Week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Misbah Ghous, MSNMPT, RIPHAH INTERNATIONAL UNIVERSITY ISLAMABAD
Publications and helpful links
General Publications
- Gupta AK, Sharma KG, Sharma P. Effect of Epley, Semont Maneuvers and Brandt-Daroff Exercise on Quality of Life in Patients with Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo (PSCBPPV). Indian J Otolaryngol Head Neck Surg. 2019 Mar;71(1):99-103. doi: 10.1007/s12070-018-1322-7. Epub 2018 Mar 30.
- Maranhao ET, Whitney SL, Maranhao-Filho P. Tumarkin-like phenomenon as a sign of therapeutic success in benign paroxysmal positional vertigo. Arq Neuropsiquiatr. 2018 Aug;76(8):534-538. doi: 10.1590/0004-282X20180073.
- Beeumen N Van. Faculteit Geneeskunde en Levenswetenschappen master in de revalidatiewetenschappen en de kinesitherapie Faculteit Geneeskunde en Levenswetenschappen master in de revalidatiewetenschappen en de kinesitherapie. 2018
- Zhang YX, Wu CL, Zhong FF, Ding CN. Evaluation of efficacies and recurrence rates of three self-treatment maneuvers for posterior semicircular canal benign paroxysmal positional vertigo. Int J Clin Exp Med. 2016;9(6):11780-7
- Kinne BL. Benign paroxysmal positional vertigo. Eye Mov Disord (Nystagmus Strabismus) Diagnosis, Manag Impact Qual Life. 2014;9(1):1-30.
- Desai DS, Chauhan AS, Trivedi MN. Role of modified Epley's maneuver and Brandt-Daroff exercises in treatment of posterior canal BPPV: a comparative study. Int J Physiother Res. 2015;3(3):1059-64.
- Manayil John HG, John A. Efficacy of Epley'S Manoeuvre in Posterior Canal Benign Paroxysmal Positional Vertigo. J Evid Based Med Healthc. 2016;3(102):5624-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00744 M Jaffar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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